The Lead

One of the criticisms of medical device OEM M&A is that too much of it eliminates competition and could result in less innovation for a particular technology. The same criticism could be true of the supply chain as well. If a company...

As medical treatment improves dramatically, allowing us to live longer lives, neurodegenerative diseases such as Alzheimer’s disease and Parkinson’s are becoming increasingly prevalent. Close to 40 million people suffer from Alzheimer’s...

2014 was a strong year for rare disease product development at FDA. It was also a year of significant firsts. In recognition of Rare Disease Day, February 28th, we want to reflect on the progress we have made thus far as we renew our commitment...

3D Icon’s imaging technology is poised to profoundly impact medical device development as well as healthcare practices. An upgrade on existing 3D imaging systems, “CSpace” provides an incredibly realistic display that you might as well be...

My PhD project develops a novel methodology to test the performance of bone and cartilage substitutions in a natural knee joint using a knee simulator. It can be used for the pre-clinical testing of tissue substitutions or for investigating...

Smart fabric technology has a great deal to offer patient monitoring. Sensors integrated right into the textile provide the least annoying way to monitor vitals, because you’ll notice it about the same as you would notice any other type...

With increasing focus to improve patient outcomes and reduce costs, the importance of continuously monitoring patients throughout their treatment pathway in the hospital is growing. Continuous monitoring is not only demanded in high-acuity...

Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum). Duodenoscopes are used in more than 500,000 procedures, called endoscopic retrograde cholangiopancreatography...

Oral implantation of “microchips” has long been a focus of conspiracy theorists, but advances in both miniaturization and medical software mean this oft-ridiculed concept is quickly becoming reality. Almost every dentist that’s been practicing...

Despite rigorous premarket evaluation, what really counts is how well a medical device works when it’s used day-to-day by patients, caregivers and clinicians. Beyond clinical trials, real-life patient experience may reveal unanticipated...

Something a smartphone can never accomplish is acquiring a medical degree. (Yet, as those who live in the constant fear of a robot uprising will say.) The so-called “melanoma diagnostic apps” MelApp and Mole Detective have learned this...

In June, the Food and Drug Administration (FDA) announced its intention to reclassify cranial electrotherapy stimulation (CES) devices from a class III to a class II designation, ending a battle that the CES industry has fought with the...

The advent of smartphones and other mobile devices has given us a daily mechanism to share and access information on an unprecedented level. Consider how a smartphone can transform the simple ritual of getting a caffeine fix. An integrated...

During my recent visit to ECRI to hear more about their watch list for safety innovations in healthcare, the topic of alarm fatigue was brought up. In fact, it’s an item that comes up quite often at ECRI in terms of their hazards lists [#1 concern on the list for the past four years (check out the...

Much of the focus of implants to date has been in vascular and circulatory. I think more time will start to be placed in the other systems – neural, musculature, and lymphatic. It all comes back to the driver of making the patient feel as...

Spanish smartphone maker Geeksphone is introducing a functionality that will really get your heart racing into its soon-to-be released wearable fitness tracker, GeeksMe. It’s basically a traditional fitness monitor, including a step counter...